Kornimate/medical-research-clean huggingface dataset:
atherectomy vs intravascular lithotripsy

Conditions: Coronary Artery Disease

Summary: preliminary experiences show that ivl is promising for achieving an effective plaque modification at time of pci. however, uncertainty about the optimal tool to select in case of calcification of coronary lesions exists, as no randomized comparisons between rotational atherectomy and intravascular lithotripsy have been carried out so far. the aim of this pilot randomized trial is to evaluate the efficacy and safety of intensive plaque modification with rotational atherectomy vs. intravascular lithotripsy before placement of a drug-eluting stent.

calcification of the coronary lesion is challenging during percutaneous coronary intervention (pci) since it can cause the balloon dilation to fail with subsequent incomplete and asymmetrical stent expansion. also, calcified coronary lesions are associated with increased risk of adverse events after pci, such as stent restenosis and thrombosis. several devices and techniques have been proposed to treat severely calcified coronary lesions. for many years, modification of these lesions with rotational atherectomy has been considered the gold standard to ease the process of angioplasty and pci. recently, intravascular lithotripsy (ivl) has been proposed as an alternative to rotational atherectomy for the treatment of calcified de-novo coronary lesions. the shockwave medical coronary rx intravascular lithotripsy (ivl) system (shockwave medical inc., fremont, california, usa) is a novel balloon catheter-based device able to disrupt calcified lesions using technology like lithotripsy for kidney stones. preliminary experiences show that ivl is promising for achieving an effective plaque modification at time of pci. however, uncertainty about the optimal tool to select in case of calcification of coronary lesions exists, as no randomized comparisons between rotational atherectomy and intravascular lithotripsy have been carried out so far. the aim of this pilot randomized trial is to evaluate the efficacy and safety of intensive plaque modification with rotational atherectomy vs. intravascular lithotripsy before placement of a drug-eluting stent.

Eligibility criteria:
inclusion criteria: * reference vessel diameter of 2.5-4.0 mm and lesion lengths of 40 mm or less involving a de novo coronary stenosis. * vessel calcification must be severe angiographically as evidenced by calcium present on both sides of the vessel and extending ≥15 mm or by intravascular ultrasound (ivus) or optical coherence tomography (oct) with presence of a calcium arc ≥270° in at least one cross-section. * calcifications should not be unable to cross with a balloon exclusion criteria: • patients with acute coronary syndromes

Keywords: coronary artery disease calcium percutaneous coronary intervention
the association between monocyte subsets and coronary collateral development in diabetes mellitus

Conditions: Coronary Artery Disease

Summary: monocyte heterogeneity in peripheral blood seems to be important in coronary collateral development in non-diabetic patients with stable coronary artery disease. our aim in this study is to find out any possible relationship between the levels of circulating monocyte subsets and coronary collateral development in type 2 diabetic patients.

83 diabetic patients with severe coronary artery disease were enrolled in the study. these patients were investigated according to their collateral development. monocytes and their subtypes, namely cd14++cd16- and cd14+cd16+ cells were compared in 2 groups

Eligibility criteria:
inclusion criteria: * presence of \> 95% stenosis of at least one major coronary artery in their first coronary angiogram. exclusion criteria: * patients experiencing acute coronary syndrome either with or without st elevation in the last one month * evidence of ongoing infection and inflammation, known malignancy and chronic kidney disease

Keywords: coronary collaterals diabetes mellitus monocyte subsets
prevalence studies after triple drug therapy for lymphatic filariasis

Conditions: Lymphatic Filariases

Summary: this study will assess the impact of 2-drug (da) or 3-drug (ida) regimens on lymphatic filariasis infection parameters in communities. parameters measured will include: circulating filarial antigenemia (cfa) assessed with the filariasis test strip (fts), antifilarial antibodies tested with plasma and microfilaremia (assessed by night blood smears and microscopy).

results from clinical trials in papua new guinea and cote d'ivoire have shown that a single dose of three drugs (ivermectin, diethylcarbamazine, and albendazole \[ida\]) was superior to standard two drug therapy (diethylcarbamazine and albendazole \[da\]) in clearing w. bancrofti microfilaremia (mf) (king et al. unpublished data).1 recently, large safety studies that treated more than 23,000 participants across four countries were conducted to determine if ida was safe for use in mass drug administration (mda) (dolf project, unpublished data). currently, there is no information about what community indicators of infection look like following shorter ida programs. it is possible that current who guidelines for stopping mda need to be modified for mda programs that use ida. observing the levels of infection indicators in a community following treatment with ida will provide important information to the gpelf if ida is recommended for use in mda programs. there is an opportunity to study communities that were treated with ida during the "community based safety study of 2-drug (diethylcarbamazine and albendazole) versus 3-drug (ivermectin, diethylcarbamazine and albendazole) therapy for lymphatic filariasis". communities in this study were randomly assigned to receive ida or da treatment. a large percentage of individuals in these communities participated in the study thereby approximating a mass distribution of the treatments. by surveying these communities 12 months following their initial treatment the investigators will be able to better understand and compare the impact of mda with ida or da on lf infection parameters at the level of communities.

Eligibility criteria:
inclusion criteria: * age ≥ 5 years (males and females) * able to provide informed consent, or parental/guardian consent for young children, and assent for older children exclusion criteria: * unable or unwilling to provide informed consent or (for minors) lacking parental/guardian consent to participate in the study

Keywords: mass drug administration effectiveness
enb in the diagnosis of peripheral pulmonary nodules

Conditions: Peripheral Pulmonary Nodules

Summary: the study is designed as a multi-center prospective trial with two arms, enb-ebus-gs group and ebus-gs group, and aimed to evaluate the diagnostic yield and operation time between the two groups.

the study is designed as a multi-center prospective trial with two arms, enb-ebus-gs group and ebus-gs group, and aimed to evaluate the diagnostic yield and operation time between the two groups. patients with peripheral pulmonary nodules that need to be confirmed by pathology will be enrolled in the study. a total of 400 patients are expected to be enrolled. ebus will be used in both group. biopsy, brushing and washing will be performed when ebus image present. brushing, washing and lavage will be performed when ebus image absent.

Eligibility criteria:
inclusion criteria: 1. patients who are older than 18 year-old. 2. chest ct shows peripheral pulmonary nodule (8mm\<longest diameter≤30mm) suspected to be malignant that need to be confirmed by pathology. the nodule is surrounded by lung parenchyma and invisible in standard bronchoscopy. 3. patients who agree to undergo bronchoscopy without any contraindications. 4. patients who have good compliance and sign informed consent. exclusion criteria: 1. chest ct scan shows that the pulmonary nodule is pure ground glass opacity. 2. presence of concomitant endobronchial lesion during the brochoscopy procerdure. 3. severe cardiopulmonary dysfunction and other indications that can't receive bronchoscopy.

Keywords: electromagnetic navigation bronchoscopy(enb) peripheral pulmonary nodules diagnostic yield
rtarup: long-term analysis

Conditions: Umbilical Hernia; TARUP; Robotic Abdominal Wall Surgery

Summary: the aim of the study is to assess the recurrence rate and potential long-term complications, at least 48 months, after a robotic assisted transabdominal retromuscular approach (rtarup technique) for the repair of an umbilical hernia.

the rtarup technique (robotic assisted transabdominal retromuscular umbilical prosthetic repair) has been introduced in the latest years for the treatment of ventral/umbilical hernias. short-term analyses have proven that this technique can be performed safely and without complications. the technique maintains the benefits of a traditional laparoscopic approach (smaller incision, faster recovery, shorter hospital stay) and obeys mesh complications related to intraperitoneal mesh placement (adhesions, pain due to mesh fixation). an initial evaluation was conducted at our center to assess recurrence and complications 1 year after the procedure in a patient group of 203 patients. we documented 3 patients with a recurrence of which 2 of them had a laparoscopic intra-peritoneal hernia repair to treat the recurrence. due to covid-19 restrictions a clinical follow-up was only possible in 73% of patients. therefore, we believe that a longer follow-up period of at least 48 months after surgery is necessary and surgically relevant to analyze the primary (recurrence rate) and secondary (long-term complications) end points of the recently introduced rtarup technique for the treatment of ventral/umbilical hernias. muysoms, f., et al., robotic transabdominal retromuscular umbilical prosthetic hernia repair (tarup): observational study on the operative time during the learning curve. hernia, 2018. 22(6): p. 1101-1111. muysoms, f., et al., observational study with one year follow-up on robotic assisted retro-rectus ventral hernia repair (rtarup) with a self-fixating mesh. br j surg, 2021. 108(suppl 8).

Eligibility criteria:
inclusion criteria: * patients that underwent rtarup procedure in the period september 2016 - december 2019 * lateral approach to the retromuscular plane/lateral single docking * use of progrip self-fixating mesh exclusion criteria: * ventral hernia on the lateral side or combined hernia (lateral and medial) * etep approach to the retromuscular plane * use of any other mesh than progrip self-fixating mesh.
experimental control investigation of the impact of assistive technology on the user-caregiver dyad: a multi-site trial

Conditions: Mobility Limitations

Summary: the purpose of this study is to determine the effectiveness of an assistive technology updating and tune up intervention on users and their caregivers. this intervention includes 4 components: * an in-residence assessment of the mobility preferences of the older person and his/her caregiver * a detailed review of forms of assistance, technological and human, that are currently being used * recommendations by an occupational therapist for possible changes in the older person's mobility assistive technology or assistance strategy * therapist negotiation of an mobility assistive technology updating and tune-up intervention plan with the individual and his or her caregiver. the intervention is provided to the immediate treatment following the administration of baseline measures and the delayed intervention group six weeks later, after an additional baseline measurement. the treatment is six weeks long and the follow-up is 26 weeks. hypothesis 1: for community-dwelling older people, an intervention that increases the appropriateness of existing or new assistive technology(at) for mobility or self-care will alter established patterns of human assistance, such that caregiver burden is reduced or eliminated. hypothesis 2: at the same time, at users will report less difficulty in mobility or self-care, as well as enhanced subjective well-being, and satisfaction with their modified personal assistance strategy. hypothesis 3: following the at intervention, caregivers will report reduced physical and/or psychological demands and increased satisfaction with their caregiving-related activities compared with * the pre-intervention period * caregivers in a delayed intervention control group. hypothesis 4: decreased physical and/or psychological demands on helpers will be associated with increases in device users' satisfaction with their personal assistance strategies.


Eligibility criteria:
inclusion criteria: * users: aged 65 years and over * have moderate to severe disability that limits their ability to move from place to place independently and/or to perform self-care activities. * living at home * receiving 2 or more hour per week of assistance with mobility and/or self-care activities from a non-professional, caregiver who is also willing to take part in the study. * those caregivers will be adults aged 18 years and over. exclusion criteria: * assistive technology users will be excluded if they have severe aphasia, are currently on a community occupational therapist caseload, or are unable to communicate in english or french.

Keywords: assistive technology mobility limitation physical disability caregiver participation
arthroscopic rotator cuff repair with multimodal analgesia(mma)

Conditions: Rotator Cuff Tear

Summary: * the purpose of this study is to compare the efficacy of periarticular injections consisting of ropivacaine, morphine, epinephrine, cefotetan, and hyaluronic acid with the efficacy of periarticular injections consisting of the same amount of placebo(isotonic saline) during arthroscopic rotator cuff repair. * adding of multimodal analgesia(mma) to conventional rotator cuff repair, it was expected that could reduce postoperative pain and narcotic consumption.


Eligibility criteria:
inclusion criteria: * rotator cuff tear * arthroscopic surgery exclusion criteria: * age\ 85 * allergies to the drugs used in the study * acute trauma history * history of renal disease * history of hepatic disease * osteoarthritis or rheumatic arthritis * systemic condition with chronic pain * history of infection * could not understand the questions * rotator cuff tear treated by the open technique, by debridement only
osteoporosis among men treated with androgen deprivation for prostate cancer

Conditions: Prostate Cancer; Androgen Deprivation Therapy; Osteoporosis

Summary: the purpose of this study is * to determine the rate of osteoporosis among patients with advanced prostate cancer. * to propose an algorithm for early detection of patients with advanced prostate cancer who are at risk of developing osteoporosis.

patients with advanced prostate cancer are included at the initiating of androgen deprivation therapy. the patients are followed for 2 years after inclusion with blood sampling, dxa-scan, questionnaire, bone scintigraphy.

Eligibility criteria:
inclusion criteria: * prostate cancer * initiation of androgen deprivation therapy * oral and written informed consent exclusion criteria: * they withdraw their consent * treatment for osteoporosis within the last year * other malignancy * other bone disease, bedbound, use of steroid

Keywords: prostate cancer androgen deprivation therapy osteoporosis
high-intensity interval training in the early subacute stroke with a semi-recumbent bike

Conditions: Stroke, Acute

Summary: although high-intensity interval training (hiit) exercise has emerged in recent years as a powerful time-efficient alternative to moderate-intensity continuous cardiovascular exercise training (mict) to enhance neuroplasticity, motor, and cognitive functions, its feasibility remains to be determined early after stroke. our study aims to investigate the feasibility of the hiit program and its effects on functional abilities, cognitive function, and quality of life in early post-stroke.

study design, setting, and ethical considerations: this study will be a prospective pre-post study that will be conducted at the university hospital of parakou in benin. the study protocol will be submitted to the ethics committee of hasselt university in belgium and the local biomedical ethics committee of the university of parakou, republic of benin. interventions: the experimental protocol will be preceded by 30 minutes of conventional physiotherapy, including neuromuscular interventions (balance training, postural awareness), musculoskeletal interventions (passive range of motion, stretching, strengthening), and lower-intensity overground walking. the conventional physiotherapy will be followed by 15 min of the rest period, then the experimental protocol consisting of a hiit program on a recumbent cycle sole r92 (hiit-rec) will be performed three times per week for six successive weeks.21 training will be performed on non-consecutive days, thereby permitting recovery between sessions. the hiit procedure will start at 4-min at 30% of the peak workload interspersed with 1-min at 70% of the peak workload at 50 rpm for weeks 1-2 and increased by approximately 5 minutes every two weeks as tolerated to reach 30 minutes from week 5 (4 to 6 repetitions). the training intensity will progress similarly by 5% peak workload two weeks as tolerated to reach 4-min at 40% peak workload interspersed with 1-min 80% peak workload from week-5.22 all sessions will be supervised and performed individually with verbal encouragement.

Eligibility criteria:
inclusion criteria: 1. first episode from an ischemic or hemorrhagic stroke confirmed by ct scan; 2. muscular weakness of the leg on the hemiplegic side defined as nihss-item 6 score between 1 and 3; 3. ashworth score of 0 or 1, indicating no spasticity or slight spasticity over the affected lower limb, respectively 4. able to walk at least 5 meters independently with or without assistive devices and understand spoken instructions; 5. living in parakou or the surrounding area and wishing to undergo the program at the hospital. exclusion criteria: participants: 1. unable to perform a graded exercise test, i.e., unable to maintain the designated pedaling rate; 2. cardiovascular diseases (uncontrolled arrhythmias, decompensated heart failure or recent myocardial injury, arteriopathy); 3. primary orthopedic conditions (fractures, active rheumatoid arthritis); 4. other neurological diseases such as (parkinson's disease and alzheimer's disease).
meal composition and the influence on pre-prandial blood glucose values

Conditions: Diabetes in Pregnancy

Summary: the purpose of the proposed study is to assess the distribution of carbohydrates and fat in the diet of women with type 1 diabetes during pregnancy. more specifically, it will look at the distribution of carbohydrate in the diet during weeks 29-32 of pregnancy. the carbohydrate distribution and fat content of the meal will be compared to maternal glucose control, preprandial glucose levels, and the percentile for weight of the infant at birth. in addition, each meal and snack will be classified as low-moderate fat or high fat.

this is a retrospective chart review. data will be collected on all patients seen whose blood sugar and food logs were at least 75% complete. by calculating carbohydrate amounts at meals and snacks, as well as classifying meals and snacks as high fat, we will examine the correlation to higher preprandial blood glucose values and large for gestational age infants. preprandial glucose levels will be reviewed, questioning whether the biggest contributor is the composition of the previous meal or additional snacks between meals.

Eligibility criteria:
inclusion criteria: * female, age 16-45, all ethnic groups, * type 1 diabetes * blood glucose logs at least 75% complete * food intake records during weeks 29-32 that are at least 75% complete exclusion criteria: * maternal medical conditions: * renal disease * restrictive lung disease * cyanotic heart disease (severe heart disease where mother is blue) * antiphospholipid antibody syndrome * collagen-vascular disease (lupus) * substance use and abuse (drugs) * multiple gestation * genetic disorders * severe malnutrition
safety, tolerability, and efficacy of ellaone® (ulipristal acetate) for emergency contraception in postmenarcheal adolescent girls and women

Conditions: Contraception

Summary: the purpose of this observational study is to assess the safety and tolerability of ellaone® in routine conditions of use for emergency contraception in postmenarcheal adolescents and adult women who want to prevent pregnancy up to 5 days after unprotected sexual intercourse.


Eligibility criteria:
inclusion criteria: * having received ellaone® as emergency contraception at the clinical site * postmenarcheal adolescents or adult women * willing to provide information on bleeding, sexual intercourses, method of contraception, concomitant medications and adverse events for the next two menstrual periods and to complete the diary accordingly * willing to provide information on pregnancy outcome / delivery and newborn's health at delivery * able to provide written informed consent * willing to not participate in a clinical trial before the end of study participation exclusion criteria: * currently participating in any interventional clinical trial (testing an investigational medicinal product)

Keywords: contraceptive methods female contraception
neoadjuvant chemotherapy of 6 cycles vs 8 cycles in node positve breast cancer

Conditions: Breast Cancer

Summary: various regimens and schedule as neoadjuvant chemotherapy regimens were investigated and sequential treatment of anthracyclines followed by taxanes, which has shown superior pathologic complete respone (pcr) rate (nsabp-b27 study) is widely used until now. considering the proven efficacy and tolerable toxicity of 3 cycles of fec followed by 3 cycles of docetaxel (fec3-d3) compared to fec 6 cycles in adjuvant chemotherapy (pacs 01 trial), use of fec3-d3 regimen in neoadjuvant setting will be feasible with acceptable efficacy and further reduce the duration of neoadjuvant chemotherapy.

to investigate feasibility of fec3-d3 regimen in neoadjuvant setting in terms of comparable efficacy and shorter duration across all subtypes.

Eligibility criteria:
inclusion criteria: * performance status 0 or 1 * clinically stage 2 or 3 with histologically proven lymph node involvement * tumor or lymph node greater than 1.5 cm exclusion criteria: * pregnancy or lactation * prior chemotherapy or radiotherapy for any malignancy * documented history of cardiac disease contraindicating anthracyclines * currently active infection

Keywords: breast cancer neoadjuvant different number of chemotherapy cycles